A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02504645
• Date of registration: 17/07/2015
• Prospective Registration: No
• Primary sponsor: ImmuPharma
• Public title: A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus LUPUZOR
• Scientific title: A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
• Date of first enrolment: March 2015
• Target sample size: 202
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02504645
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Czech Republic, Czechia, France, Germany, Hungary, Italy, Mauritius, Poland, Puerto Rico, United States

Contacts

• Name: Daniel WALLACE
• Affiliation: Wallace Rheumatic Studies Center LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- The patient is a man or woman between 18 and 70 years of age with an established
diagnosis of SLE as defined by ACR Classification Revised Criteria. The diagnosis is
fulfilled provided that at least 4 criteria are met.

- The patient has a positive test result for ANA at screening (titer must be at least
1:80 [by human epithelial cell tumor line (HEp-2) ANA assay]) and/or a positive test
result for anti-dsDNA Ab at screening (value must be 30 IU/mL or more by enzyme-linked
immunosorbent assay [ELISA]).

- Written informed consent is obtained.

- Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing
potential, using a medically accepted method of contraception, and must agree to
continued use of this method for the duration of the study and for 30 days after
discontinuation of study drug treatment. Acceptable methods of contraception include
barrier method with spermicide, abstinence (when this is in line with the preferred
and usual lifestyle of the subject), intrauterine device (IUD), or steroidal
contraceptive (oral, transdermal, implanted, and injected) in conjunction with a
barrier method.

- The patient has a SLEDAI-2K clinical score of at least 6 points during screening. A
SLEDAI-2K clinical score is the calculated score without inclusion of the points that
may be contributed by having a positive titer for anti-dsDNA Ab or decreased serum
complement levels.

- The patient does not have an "A" score on the BILAG-2004 scale. If the patient is
using oral corticosteroids, the weekly cumulative dose must not exceed 80 mg of
prednisone equivalent; the weekly dose must be stable over the 4 weeks preceding the
1st dose of study drug.

- If the patient is using antimalarials, methotrexate, leflunomide, mycophenolate
mofetil (MMF), or azathioprine, the start date must be at least 3 months prior to the
1st dose of study drug, and the daily dose must be stable over the 4 weeks preceding
the 1st dose of study drug.

- If the patient is not currently using corticosteroids, antimalarials, methotrexate,
MMF, or azathioprine, the last dose (in case of previous use) must be at least 4 weeks
prior to the 1st dose of study drug. For leflunomide, the stop date must be at least 8
weeks before the 1st dose of study drug unless an adequate cholestryamine washout has
been performed. If cholestyramine washout is performed, the last use of leflunomide
must be at least 4 weeks before the 1st dose of study drug.

- The patient must be willing and able to comply with study restrictions, to remain at
the study center for the required duration during each study visit, and to return to
the study center for the final assessment as specified in this protocol.

Exclusion Criteria:

- The patient has been treated with intramuscular or intravenous (iv) pulse steroids
(ie, 250 to 1000 mg iv total daily dose of methylprednisolone) within 4 weeks of the
1st dose of study drug. The use of intra-articular steroids may be allowed after
consultation with the medical expert.

- The patient has received tacrolimus, cyclosporin A, or iv immunoglobulins (IVIG)
within 3 months of the 1st dose of study drug.

- The patient has received cyclophosphamide within 6 months prior to the 1st dose of
study drug.

- The patient has been treated for SLE with agents such as fusion proteins, therapeutic
proteins, or monoclonal antibodies or antibody fragments, within 6 months of the 1st
dose of study drug.

- The patient has received B-cell depleting agents such as rituximab, belimumab or
epratuzumab within one year of the 1st dose and has not yet normalized the B-cell
count (ie, CD20+ B-cell count is less than normal range and the absolute lymphocyte
count [ALC] is less than normal range).

- The patient has New York Heart Association (NYHA) Class III or IV congestive heart
failure.

- The patient has an estimated glomerular filtration rate (eGFR) of less than 30
mL/min/1.73 m2 (via Modification of Diet in Renal Disease [MDRD] equation).

- The patient has an aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
value greater than 2 times the upper limit of the normal range (ULN) or a total
bilirubin level greater than 1.5 times ULN.

- The patient has a planned immunization with a live or live attenuated vaccine within 3
months prior to administration of the 1st dose of study drug and for 3 months after
administration of the last dose of study drug.

- The patient has any clinically significant abnormalities on ECG that are not related
to SLE, as determined by the investigator. Patients with stable ECG changes without
evidence of active cardiovascular disease may participate at the discretion of the
investigator and medical monitor.

- The patient has an ongoing active systemic infection requiring treatment or a history
of severe infection, such as hepatitis or pneumonia, in the 3 months prior to
administration of the 1st dose of study drug. Less severe infections in the 3 months
prior to administration of the 1st dose of study drug are permitted at the discretion
of the investigator and medical monitor.

- The patient has any concomitant medical condition unrelated to SLE that may interfere
with his or her safety or with evaluation of the study drug, as determined by the
investigator.

- The patient has a history of a medical condition other than SLE that has required
treatment with oral corticosteroids in excess of 80 mg of prednisone equivalent/week
within 3 months of the 1st dose of study drug.

- The patient has a positive test result for hepatitis B surface antigen (HBsAg) or
hepatitis C virus antibody (HCV Ab).

- The patient has a known positive history of antibodies to human immunodeficiency virus
(HIV) or HIV disease or other immunosuppressive state (eg, agammaglobulinemia, etc).

- The patient has a history of alcohol or substance dependence or abuse (with the
exception of nicotine),according to the Diagnostic and Statistical Manual of Mental
Disorders of the American Psychiatric Association, Fourth Edition, Text Revision
(DSM-IV-TR), within 3 months of the screening visit or has current substance abuse.

- The patient has a history of severe allergic reactions to or hypersensitivity to any
component of the study drug or placebo.

- The patient has undergone or is undergoing treatment with another investigational drug
for the treatment of lupus within 6 months prio


Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Drug: Placebo

Other: Standard of Care

Drug: IPP-201101

Primary Outcome(s)

Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at Week 52 [Time Frame: At week 52]

Secondary ID(s)

IPP-201101/005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/04/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02504645